ordic Pancreatic Cancer Trial

Phase 1

• Conditions: Resectable pancreatic cancer; MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001635-21-DK
• Lead Sponsor: orwegian Gastointestinal Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-05
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Resectable pancreatic cancer
Performance status 0-2
Histologically confirmed diagnosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Metastatic disease
Non-resectable primary pancreatic cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall survival 1 year after surgery;Secondary Objective: Disease free survival (DFS)<br>Number of positive lymph nodes in surgical specimen<br>Resection margin (RO);Primary end point(s): Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection (ie: only resected patients analyzed).;Timepoint(s) of evaluation of this end point: 1 year after surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival following resection<br>Disease free survival (DFS)<br>Number of positive lymph nodes in surgical specimen<br>Resection margin (RO)<br>Exploratory translational research;Timepoint(s) of evaluation of this end point: CT scans 3, 6 and 12 months after surgery